| CTRI Number |
CTRI/2023/01/049347 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Myopia. |
|
Scientific Title of Study
|
"A Clinical study to evaluate the efficacy of panchendriyavardhana taila nasya and dhatryadi rasakriyanjana in Prathama patalagata timira with special
reference to simple myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUMA T L |
| Designation |
PG SCHOLAR |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of PG studies in Shalakya Tantra, Shalakya tantra OPD,Room no.11, Government ayurveda medical college, Dhanwantari road Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
7829445349 |
| Fax |
|
| Email |
tlsuma05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Syed Munawar PASHA |
| Designation |
MS AYU |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of PG studies in Shalakya Tantra, Shalakya tantra OPD,Room no.11, Government ayurveda medical college, Dhanwantari road Bangalore
Department of PG studies in Shalakya Tantra, Shalakya tantra OPD,Room no.11, Government ayurveda medical college, Dhanwantari road Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Syed Munawar PASHA |
| Designation |
Professor |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of PG studies in Shalakya Tantra, Shalakya tantra OPD,Room no.11, Government ayurveda medical college, Dhanwantari road Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayachamarajendra Institute of Indian Medicine Hospital, Government ayurveda medical college campus, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Suma T L |
| Address |
Government ayurveda medical college Bangalore-09 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suma T L |
Sri Jayachamarajendra Institute of Indian medicine hospital |
Shalakya tantra OPD, Room No.11. Government Ayurveda medical college,Campus, Dhanwantari road Bangalore-560009 Bangalore Karnataka
Bangalore
KARNATAKA |
7829445349
tlsuma05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Ayurveda medical college Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charaka samhita siddi stana chapter no-9, Procedure details: Abhyanga will be done with moorchita tila taila followed by mridu sweda. Advise the patient to lie down in supine position on nasya table. Instill panchendriya vardhana taila to each nostril and ask the patient to spit kaphadi doshas once it enters the throat.)
(1) Medicine Name: Panchendriyavardhana taila, Reference: kashyapa samhita shtakalpa adhyaya, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | anjana | (Procedure Reference: Charaka samhita sutra stana chapter no 5, Procedure details: The patient is asked to open eye widely then apply anjana using the shalaka from aknika sandhi to apanga sandhi.)
(1) Medicine Name: Dhatryadi rasakriyanjana, Reference: Charaka samhita uutara tantra chapter no -26., Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(mg), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects irrespective of gender, caste, religion.
2.Subjects presenting with clinically established cases of simple myopia.
3.Patients having -0.25D to -6D of vision. |
|
| ExclusionCriteria |
| Details |
1. Pathological myopia, high myopia with degenerative and gross retinal changes.
2. Myopia associated with structural deformities like corneal opacity, keratoconus, keratoglobus.
3. Subjects who have underwent any of the refractive surgeries.
4. Subjects who are contraindicated for nasya and anjana. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual acuity- Snellens chart reading
2. Autorefraction |
44 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blurred vision |
44 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prathama patalagata Timira is one among the drishtigata netra rogas.Avyakta darshana (Impairement in vision) is the main lakshana mentioned under prathama patalagata timira.The lakshanas of prathama patalagata timira can be equated with the signs and symptoms of Simple Myopia.Simple myopia is the most common refractive error seen in young children and adults.Globally myopia is the leading cause of distance refractive error affecting 1.45 billion or 27% of the world population in 20101.According to sight saving review (1979) myopia is the 4th major cause of visual loss after cataract,glaucoma,and senile macular degeneration .The number of people with myopia is expected to continue to rise both in absolute numbers and as a percentage of the population. As such there is no effective treatment for myopia only optical correction by spectacles or contact lenses to restore distant vision is advised.It fails to decrease the risk of posterior segment sequel of myopia .Surgical intervention is advised only in condition of stabilized myopia and complication such as dry eye and night glare are common.moreover the cost of surgery makes it fearful and less opted procedure.hence an alternative treatment which is safe,devoid of complication ,cost effective is the need of the hour .Considering all these facts ,this work “A CLINICAL STUDY TO EVALUATE THE EFFICACY OF PANCHENDRIYA VARDHANA TAILA NASYA AND DHATRYADI RASAKRIYANJANA IN PRATHAMA PATALAGATA TIMIRA WITH SPECIAL REFERENCE TO SIMPLE MYOPIA†is been taken up |